Duloxetine

Product NDC
70518-0343
11-digit product format
705180343
Labeler code
70518
Product ID
70518-0343_e157b4cf-eeb1-c515-e053-2a95a90aa260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DULOXETINE HYDROCHLORIDE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203088
Marketing category
ANDA
Marketing start
2017-03-20
Marketing end
0000-00-00
Substance
DULOXETINE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-0343-07051803430030 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK (70518-0343-0) 2017-03-200000-00-00NoNoCurrent
70518-0343-17051803430130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (70518-0343-1) 2017-04-030000-00-00NoNoCurrent